Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Fizazi, Karim; Herrmann, Ken; Krause, Bernd J.; Rahbar, Kambiz; N., Kim; Morris, Michael J.; Sartor, Oliver; Tagawa, Scott T.; Kendi, Ayse T.; Vogelzang, Nicholas J.; Calais, Jérémie; Nagarajah, James; Wei, Xiao X.; Koshkin, Vadim S.; Beauregard, Jean-Mathieu; Chang, Brian; Ghouse, Ray; DeSilvio, Michelle; Messmann, Richard A.; Bono, Johann S. de

doi:10.1016/s1470-2045(23)00158-4

Cited by 44 publications

(14 citation statements)

References 31 publications

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“…Despite the higher toxicity of 177 Lu-PSMA-61 compared with standard of care alone (52.7% vs 38.0%, respectively), quality of life strongly favored PSMA-617. 34,35 The CTRI/2019/12/022282 clinical trial analyzed the use of 177…”

Section: Castration-resistant Prostate Cancermentioning

confidence: 99%

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PSMA Radioligand Therapy in Prostate Cancer

Almeida,

Etchebehere,

García Megías

et al. 2023

Clin Nucl Med

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Diagnosis and treatment of prostate cancer are complex and very challenging, being a major health care burden. The efficacy of radioligand therapy with prostate-specific membrane antigen agents has been proven beneficial in certain clinical indications. In this review, we describe management of prostate cancer patients according to current guidelines, especially focusing on the available clinical evidence for prostate-specific membrane antigen radioligand therapy.

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Section: Castration-resistant Prostate Cancermentioning

confidence: 99%

“…Current Evidence of Clinical Trials on PSMA-RLT in Patients With mCRPC, Including Trial Design, Inclusion and Exclusion Criteria, and Outcomes[29][30][31][32][33][34][35][36][37] …”

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confidence: 99%

PSMA Radioligand Therapy in Prostate Cancer

Almeida,

Etchebehere,

García Megías

et al. 2023

Clin Nucl Med

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“…Besides the high absorbed doses of [ 161 Tb]Tb-PSMA-617 in tumor lesions, a low physiological uptake by normal organs is a required property to use this radionuclide in RLT. With respect to PSMA-RLT, the kidneys and in addition the salivary glands are usually regarded as dose-limiting organs at risk 10 , 17 . It was observed, that the radiation dose to the kidneys may increase the risk of late renal function impairment, especially in late-stage mCRPC patients 54 .…”

Section: Discussionmentioning

confidence: 99%

“…TI was defined by calculating the mean radiation dose absorbed in tumor lesions divided by the mean radiation dose delivered to a relevant organ at risk. As in the case of PSMA-RLT the relevant organs at risk are known to be the kidneys and the salivary glands 10 , 17 , the TI for the kidneys (TI-kidney) and exemplarily for the salivary glands, the TI for the parotid gland (TI-parotid) were determined. Furthermore, the ratio of the TI for [ 161 Tb]Tb-PSMA-617 to the TI for [ 177 Lu]Lu-PSMA-617 was calculated for each organ at risk and reported as relative therapeutic index (rTI-kidney and rTI-parotid).…”

Section: Methodsmentioning

confidence: 99%

[¹⁶¹Tb]Tb-PSMA-617 radioligand therapy in patients with mCRPC: preliminary dosimetry results and intra-individual head-to-head comparison to [¹⁷⁷Lu]Lu-PSMA-617

Schaefer-Schuler,

Burgard,

Blickle

et al. 2024

Theranostics

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Rationale: Evaluation of alternative radionuclides for use in prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) is currently focusing on 161 Tb, which may provide advantages by emitting additional Auger and conversion electrons. In this pilot study, we present preliminary dosimetry data for [ 161 Tb]Tb-PSMA-617 RLT in a direct comparison with [ 177 Lu]Lu-PSMA-617. Method: Six patients with metastatic castration-resistant prostate cancer (mCRPC) underwent treatment with [ 177 Lu]Lu-PSMA-617 and subsequently - after inadequate response - with [ 161 Tb]Tb-PSMA-617. Whole-body planar and SPECT imaging-based dosimetry of organs at risk (kidneys and salivary glands) and tumor lesions were calculated using IDAC for 177 Lu and OLINDA/EXM for 161 Tb. The therapeutic index (TI) of mean tumor-absorbed doses over relevant organs at risk was calculated. Results: Mean absorbed doses to organs at risk of PSMA-RLT were slightly higher for [ 161 Tb]Tb-PSMA-617 compared to [ 177 Lu]Lu-PSMA-617 (kidneys: 0.643 ± 0.247 vs. 0.545 ± 0.231 Gy/GBq, factor 1.18; parotid gland: 0.367 ± 0.198 vs. 0.329 ± 0.180 Gy/GBq, factor 1.10), but markedly higher regarding tumor lesions (6.10 ± 6.59 vs 2.59 ± 3.30 Gy/GBq, factor 2.40, p < 0.001). Consequently, the mean TI was higher for [ 161 Tb]Tb-PSMA-617 compared to [ 177 Lu]Lu-PSMA-617 for both, the kidneys (11.54 ± 9.74 vs. 5.28 ± 5.13, p = 0.002) and the parotid gland (16.77 ± 13.10 vs. 12.51 ± 18.09, p = 0.008). Conclusion: In this intra-individual head-to-head pilot study, [ 161 Tb]Tb-PSMA-617 delivered higher tumor-absorbed doses and resulted in superior TI compared to [ 177 Lu]Lu-PSMA-617. This preliminary data support 161 Tb as a promising radionuclide for PSMA-RLT in mCRPC.

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“…Of all the healthy organs, the lacrimal glands had the highest mean absorbed tumor dose of 177 Lu-PSMA-I&T and 177 Lu-PSMA-617 (5.8 vs. 5.9 Gy/GBq), but patients tolerated the therapy without any acute side effects ( 29 ). A study that further evaluated the difference in efficacy between 177 Lu-PSMA-617 plus standard therapy (hormone therapy, bisphosphonates and radiotherapy) and 177 Lu-PSMA-617 alone showed that combined therapy extended the duration of pain exacerbation compared with 177 Lu-PSMA-617 alone ( 30 ). It is hoped that future studies can include the combined use of nuclides with other drugs (such as targeted drugs and chemotherapy drugs), and it is hoped that new progress and breakthroughs can be made in the treatment of mCRPC through combination therapy.…”

Section: Application Of 177 Lu In Prostate Cancermentioning

confidence: 99%

Current clinical application of lutetium‑177 in solid tumors (Review)

Niu,

Fan,

Lin

et al. 2024

Exp Ther Med

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Radionuclide-based therapy represents a novel treatment regimen for tumors. Among these therapies, lutetium-177 ( 177 Lu) has gained significant attention due to its stability and safety, as well as its ability to emit both γ and β rays, allowing for both imaging with single photon emission computed tomography and tumor treatment. As a result, 177 Lu can be used for both diagnosis and treatment for diseases such as prostatic and gastric cancer. Therefore, based on the available data, the present review provides a brief overview of the clinical applications of 177 Lu-targeted radionuclide therapy in metastatic prostate cancer, neuroendocrine tumors and other types of solid tumors, and highlights the current therapeutic effect, reduction in damage to normal tissues and future research directions, including the development of new nuclides and the application of more nuclides in different tumors. In the future, such treatments could be used in more tumors.

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Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Cited by 44 publications

References 31 publications

PSMA Radioligand Therapy in Prostate Cancer

PSMA Radioligand Therapy in Prostate Cancer

[¹⁶¹Tb]Tb-PSMA-617 radioligand therapy in patients with mCRPC: preliminary dosimetry results and intra-individual head-to-head comparison to [¹⁷⁷Lu]Lu-PSMA-617

Current clinical application of lutetium‑177 in solid tumors (Review)

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Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Cited by 44 publications

References 31 publications

PSMA Radioligand Therapy in Prostate Cancer

PSMA Radioligand Therapy in Prostate Cancer

[161Tb]Tb-PSMA-617 radioligand therapy in patients with mCRPC: preliminary dosimetry results and intra-individual head-to-head comparison to [177Lu]Lu-PSMA-617

Current clinical application of lutetium‑177 in solid tumors (Review)

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[¹⁶¹Tb]Tb-PSMA-617 radioligand therapy in patients with mCRPC: preliminary dosimetry results and intra-individual head-to-head comparison to [¹⁷⁷Lu]Lu-PSMA-617